Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000033943
Ethics application status
Approved
Date submitted
8/01/2020
Date registered
20/01/2020
Date last updated
2/11/2021
Date data sharing statement initially provided
20/01/2020
Date results provided
2/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinician and patient perspectives of hospital falls prevention education
Scientific title
Preventing hospital falls: a qualitative analysis of the views of patients and clinicians on how to minimise risk
Secondary ID [1] 300207 0
Nil known
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Falls 315763 0
Condition category
Condition code
Public Health 314045 314045 0 0
Health service research
Injuries and Accidents 314046 314046 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an exploratory qualitative study on patient and clinician perspectives of patient education hospital falls prevention.

This study aims to:
*Explore patients’ perceptions of falls prevention education. To determine what barriers and facilitators exist in understanding and adhering to falls prevention education.
*Understand clinician knowledge, expectations, views and attitudes towards hospital falls prevention and accompanying education and training programs.

A number of focus groups will be conducted by an experienced qualitative researcher and facilitator who will not be known to participants. A note-taker will also be present during focus group sessions to capture non-verbal or emotional responses, and observations. These sessions will be audio-recorded and transcribed verbatim by an independent transcription service. The interviews will be semi-structured and subject to time constraints, participant fatigue and information gained. These questions are informed by a literature review as well as consultation with content experts. Demographic data will be collected from participants. For patient participants, these will include age, comorbidities, reason for hospitalisation, pre-morbid level of mobility and history of falls. For clinician participants, demographic data collected will be occupation, years of clinical experience, area of work (e.g. acute medical, oncology, geriatric rehabilitation).

The semi-structured interview will include questions about patient/clinician beliefs and knowledge about falls prevention, and what they want from hospital falls prevention education programs.
Intervention code [1] 316480 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322448 0
Patient perspectives on hospital falls prevention patient education as reported by thematic analysis of focus groups.
Timepoint [1] 322448 0
Following completion of approximately 8 focus groups across two months.
Primary outcome [2] 322561 0
Clinician perspectives on hospital falls prevention patient education as reported by thematic analysis of focus groups.
Timepoint [2] 322561 0
Following completion of approximately 8 focus groups across two months.
Secondary outcome [1] 378578 0
Nil
Timepoint [1] 378578 0
Nil

Eligibility
Key inclusion criteria
Patients will be included if they are: (i) adults (>18 years); (ii) able to speak, read and understand English; (iii) medically stable; and (iv) willing and able to give informed consent.

The inclusion criteria for clinicians are: (i) qualified registered nurses or allied health clinicians (physiotherapists, occupational therapists, podiatrists, dieticians, social workers) who are most likely involved in falls prevention; (ii) adults (>18 years); (iii) able to speak, read, write and understand English; and (iv) willing and able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients will be excluded if they have cognitive impairment as informally judged by nursing staff. Any clinicians who are working in non-inpatient settings will be excluded.

Study design
Purpose
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/12/2019
Date of last participant enrolment
Anticipated
28/02/2020
Actual
7/06/2021
Date of last data collection
Anticipated
28/02/2020
Actual
7/06/2021
Sample size
Target
50
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304637 0
Government body
Name [1] 304637 0
National Health and Medical Research Council
Country [1] 304637 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive, Bundoora, VIC 3086
Country
Australia
Secondary sponsor category [1] 304935 0
None
Name [1] 304935 0
N/A
Address [1] 304935 0
N/A
Country [1] 304935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305057 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 305057 0
Ethics committee country [1] 305057 0
Australia
Date submitted for ethics approval [1] 305057 0
08/08/2019
Approval date [1] 305057 0
15/10/2019
Ethics approval number [1] 305057 0
HEC19373

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99126 0
Prof Meg Morris
Address 99126 0
La Trobe University
Kingsbury Drive, Bundoora, VIC 3082
Country 99126 0
Australia
Phone 99126 0
+61 3 9479 6080
Fax 99126 0
Email 99126 0
m.morris@latrobe.edu.au
Contact person for public queries
Name 99127 0
Meg Morris
Address 99127 0
La Trobe University
Kingsbury Drive, Bundoora, VIC 3082
Country 99127 0
Australia
Phone 99127 0
+61 3 9479 6080
Fax 99127 0
Email 99127 0
m.morris@latrobe.edu.au
Contact person for scientific queries
Name 99128 0
Meg Morris
Address 99128 0
La Trobe University
Kingsbury Drive, Bundoora, VIC 3082
Country 99128 0
Australia
Phone 99128 0
+61 3 9479 6080
Fax 99128 0
Email 99128 0
m.morris@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will not be made available due to patient confidentiality.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.